Post-Marketing Safety Concerns With Secukinumab: A Disproportionality Analysis of the FDA Adverse Event Reporting System

Shu, Yamin; Ding, Yong; Liu, Yanxin; Wu, Pan; He, Xu‐Cheng; Zhang, Qilin

doi:10.3389/fphar.2022.862508

Cited by 34 publications

(27 citation statements)

References 47 publications

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“…The association between osimertinib and AEs were determined by the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) algorithms, which was based on the disproportionality analysis 50 . The equations and criteria for the four algorithms are described in Supplementary Table S1.…”

Section: Discussionmentioning

confidence: 99%

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib

Yin

Shu

Zhu

et al. 2022

Sci Rep

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Osimertinib was a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), which approved by the US Food and Drug Administration (FDA) in 2015 for treatment of non-small cell lung cancer (NSCLC). Our study was to explore the adverse events (AEs) caused by osimertinib through data mining of the US FDA Adverse Event Reporting System (FAERS), and provide reference for clinical safety. Data of osimertinib were collected from the FAERS database covering the period from first quarter of 2016 to the fourth quarter of 2021. Disproportionality analyses was employed to quantify the associated AE signals of osimertinib and detect the risk signals from the data in the FAERS database. Reporting odds ratio (ROR) was used to detect the risk signals from the data in the FAERS database. The definition relied on system organ class (SOCs) and preferred terms (PTs) by the Medical Dictionary for Regulatory Activities (MedDRA). Totally, 9,704,33 reports were collected from the FAERS database, 10,804 reports of osimertinib were identified as the ‘primary suspected (PS)’ AEs. Osimertinib induced AEs occurred in 27 organ systems. 68 significant disproportionality PTs satisfying with the four algorithms were retained at the same time. Unexpected significant AEs such as scrotal volvulus, hepatic function abnormal, venous thromboembolisms might also occur. The median onset time of osimertinib-associated AEs was 58 days (interquartile range [IQR] 14–212 days), and the majority of the AEs occurred within the first 30 days after osimertinib initiation. Our study found significant new AEs signals of osimertinib and might provide support for clinical monitoring and risk identification of osimertinib.

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Section: Discussionmentioning

confidence: 99%

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib

Yin

Shu

Zhu

et al. 2022

Sci Rep

Self Cite

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show abstract

“…The association between osimertinib and AEs were determined by the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian con dence propagation neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) algorithms, which was based on the disproportionality analysis (44). The equations and criteria for the four algorithms are described in Supplementary Table S1.…”

Section: Discussionmentioning

confidence: 99%

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for Osimertinib

Yin

Shu

Zhu

et al. 2022

Preprint

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Background Osimertinib was a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), which approved by the US Food and Drug Administration (FDA) in 2015 for treatment of non-small cell lung cancer (NSCLC). Our study was to explore the adverse events (AEs) caused by osimertinib through data mining of the US FDA Adverse Event Reporting System (FAERS), and provide reference for clinical safety. Methods Data of osimertinib were collected from the FAERS database covering the period from first quarter of 2016 to the fourth quarter of 2021. Disproportionality analyses was employed to quantify the associated AE signals of osimertinib and detect the risk signals from the data in the FAERS database. ROR was used to detect the risk signals from the data in the FAERS database. The definition relied on system organ class (SOCs) and preferred terms (PTs) by the Medical Dictionary for Regulatory Activities (MedDRA). Results Totally, 9704338 reports were collected from the FAERS database, 10804 reports of osimertinib were identified as the ‘primary suspected (PS)’ AEs. Osimertinib induced AEs occurred in 27 organ systems. 68 significant disproportionality PTs satisfying with the four algorithms were retained at the same time. Unexpected significant AEs such as scrotal volvulus, hepatic function abnormal, VTEs might also occur. The median onset time of osimertinib-associated AEs was 58 days (interquartile range [IQR] 14–212 days), and the majority of the AEs occurred within the first 30 days after osimertinib initiation. Conclusion Our study found significant new AEs signals of osimertinib and might provide support for clinical monitoring and risk identification of osimertinib.

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“…Since the database is submitted by various sources, it may sporadically include duplicate reports, so it needs to be reprocessed. The CASEID and PRIMARYID were chosen as the key filter in our study to remove duplicate records, by selecting the latest FDA_DT when CASEID were the same, and choosing the higher PRIMARYID when the CASEID and FDA_DT were the same [ 14 ], resulting in a reduction in the number of reports to 8,379,682.…”

Section: Methodsmentioning

confidence: 99%

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for venetoclax

et al. 2022

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Background Venetoclax (VEN) is the first selective small molecule Bcl-2 inhibitor approved by FDA and used in adult chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and some acute myeloid leukemia (AML). However, the long-term safety of VEN in large sample population was unknown. This study evaluated the adverse events (AEs) of VEN from FDA Adverse Event Reporting System (FAERS) since its approval in 2016 by data mining. Methods The disproportionality analyses, including four algorithms of reporting odd ratio (ROR), proportional reporting ratio (PRR), bayesian configuration promotion neural network (BCPNN), and multi item gamma poisson shrinker (MGPS), were employed to quantify the signals of VEN-associated AEs. Results From the FAERS database, a total of 8,379,682 reports were collected during the study period. After removing the duplication, the number of reports with VEN as the primary suspect (PS) was 19,107. The 19,107 cases of AEs involved 27 organ systems, 256 significant PTs which conforming to the four algorithms. Unexpected serious AEs, such as pleural effusion, splenic infarction, atrial fibrillation, skin squamous cell carcinoma, etc., have signals. The median time of occurrence of AEs related to VEN was 31 days (inter quartile range [IQR] 7–131 days), and half of the reported AEs occurred within 1 month after administration. Conclusion Our research has found new significant AEs signals of VEN, which improved its safety information in real-world after marketing approval, and contributed to its risk control of use in clinic.

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Post-Marketing Safety Concerns With Secukinumab: A Disproportionality Analysis of the FDA Adverse Event Reporting System

Cited by 34 publications

References 47 publications

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for Osimertinib

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for venetoclax

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